Lubricants have been employed for a number of applications, including lubrication of latex condoms and lubrication of skin. More recently, lubricants have been designed to take advantage of the heat that is generated when glycerin or propylene glycol is dissolved in water. Unfortunately, glycerin and propylene glycol do not spread readily on skin and other surfaces and irritate skin after prolonged use, since glycerin extracts water from the skin surface. Addition of thickeners to make the lubricants feel rich severely limits the spreadability of the lubricants. The spreadability of such lubricants is further compromised by the addition of one or more insulating agents, such as honey, isopropyl myristate and/or isopropyl palmitate, which reportedly help to retain the heat of the lubricant (see, e.g., U.S. Pat. App. Pub. Nos. 2004/0138074, 2003/0232090, 2003/0211161 and 2003/0207772, and Int'l App. Pub. Nos. WO 03/092652, WO 03/092651 and WO 09/092,650 discussed below).
U.S. Pat. No. 4,851,434 (the '434 patent) to Decker discloses a non-greasy, nonirritating moisturizer, and compositions containing as the major moisturizing component the di-, tri-, or polyglycol amide or glucamine reaction product with an α-hydroxy-substituted fatty acid, with the formula containing hydrogen or a lower alkyl, preservatives, thickeners, skin-soothing agents, such as allantoin and/or dl-panthenol, and water. The nonirritating moisturizer disclosed in the '434 patent does not produce a warming effect when it contacts body-generated moisture and does not spread spontaneously on human skin.
U.S. Pat. No. 4,952,560 to Kigasawa et al. discloses an ointment base containing a water-soluble protein consisting of gelatin, casein and soybean protein and a monohydric alcohol with a carbon number of 2 to 4 and/or an oleginous substance and additionally containing a wetting agent selected from the group consisting of an alkylene glycol containing 2 to 6 carbon atoms, polyethylene glycol having an average molecular weight of about 200 to 800, glycerin, trimethylolpropane and sorbitol, in a range of 1 to 35 weight % based on the weight of the whole ointment. While the ointment base improves percutaneous absorption of drugs, it is too thick to function as a lubricant.
U.S. Pat. No. 5,441,723 to Simmons discloses a non-toxic hypocompatible biodegradable germicide. The non-toxic hypocompatible biodegradable germicide is effective against a wide range of pathogenic organisms and comprises 65-75 wt % of a monohydric alcohol selected from the group consisting of isopropyl, methyl, ethyl, n-propyl, n-butyl, tert-butyl, allyl, or mixtures thereof, and from about 4% to about 16% by weight of at least one polyhydric alcohol selected from the group consisting of propylene glycol, 1,3 propanediol, 1,2 butanediol, PEG 400, glycerol or 1,4 butanediol, or mixtures thereof in proportion by weight. The monohydric alcohol in the germicide provides the primary disinfecting or killing effect on the pathogenic organisms, while the polyhydric alcohol reduces the surface glaze formed by the monohydric alcohol and the surface tension formed by water or water-based body fluids, thereby enabling the disinfectant/antiseptic to kill pathogenic organisms and act equally effectively on a patient or inanimate surface without deleterious effects, lowers the flash point of the composition, soothes the skin, and slows the rate of evaporation. The germicide is not a lubricant and does not include a warming constituent. In this regard, the polyhydric alcohol, by reducing the rate of evaporation of the monohydric alcohol, essentially cools the surface by evaporative cooling.
U.S. Pat. No. 5,512,289 to Tseng et al. discloses a spermicidal anti-viral lubricant composition containing a water-soluble polymeric gel matrix comprising a hydroxyalkyl cellulose with 2 to 6 carbon atoms; an alkylphenoxypolyethoxyethanol spermicide; and a solubilizing moiety comprising a polyethoxylated non-ionic compound, such as polyethoxylated castor oil. The use of an alkylphenoxypolyethoxyethanol spermicide prevents collapse of the hydroxyalkylcellulose gel. The addition of a solubilizer substantially prevents the collapse of the gel matrix and permits the gel matrix to maintain its properties in the composition. The spermicidal composition can be dispersed by use of a pharmaceutically acceptable vehicle, such as water, alcohols, e.g., ethanol, glycerin, propylene glycol, and mixtures thereof. A typical formulation of the spermicidal lubricant can include water 75.50 wt %, glycerin 17.00 wt %, hydroxyethyl cellulose 1.00 wt %, polyvinyl pyrrolidone 0.90 wt %, carboxymethyl cellulose 1.00 wt %, Nonoxynol-9 spermicide 2.00 wt %, polyethoxylated castor oil 2.00 wt %, methylparaben 0.20 wt %, sorbic acid 0.05 wt %, and citric acid 0.35 wt %. Since glycerin and glycol are already dissolved in water, the lubricant does not provide a warming effect.
U.S. Pat. No. 5,514,698 to Ahmad et al. discloses an antifungal vaginal cream composition. The composition has stable viscosity at human body temperature and comprises about 0.4 to 10.0% of an imidazole antifungal agent (of miconazole, econazole, terconazole, saperconazole, itraconazole, ketoconazole, and clotrimazole), about 1.0% to 5.0% of a fatty acid ester (isopropyl stearate, isopropyl myristate, isopropyl palmitate, and isopropyl laurate), about 1.0% to 25.0% of aliphatic alcohols (cetyl alcohol, stearyl alcohol and propylene glycol), about 2.0% to 5.0% of a surfactant (polysorbate 60 or polysorbate 80), about 0.02% to 0.20% of an antioxidant (butylated hydroxyanisole), a sufficient amount of inorganic base (NaOH or KOH) to adjust the pH range to a value of about 3.0 to 7.0, and water. This vaginal cream is not a lubricant and is expected to maintain its viscosity for prolonged time periods at body temperature. Even though propylene glycol is used in the composition, it is already mixed with water and, therefore, no warming effect takes place when the cream contacts body-generated moisture.
U.S. Pat. No. 5,649,825 to Ratkus discloses a dental root canal bacterialcidal lubricant, which allows the cleaning wires or files to move more freely when removing a nerve from a tooth. The composition reduces packing of tissue and dentin debris within the nerve cavity. This formulation is also resistive to decomposition during cold weather shipping, and includes cetyl alcohol, stearyl alcohol, sodium lauryl sulfate, stearic acid, propylene glycol, methyl paraben, propyl paraben, and butyl paraben in a purified water solution. The lubricant does not provide a warming effect.
U.S. Pat. No. 5,885,591 to Ahmad et al. discloses highly lubricious personal lubricant compositions containing one or more polyhydric alcohols, one or more water-soluble polymers derived from cellulose, water, and, optionally, preservatives and alkali metal or alkaline earth metal bases. These compositions can provide a vehicle for delivering medicaments for contraception and for the treatment and prevention of disease. The personal lubricant composition contains about 30% glycerin, about 5% propylene glycol, about 10% sorbitol, about 0.4% preservative, about 0.4% hydroxyethylcellulose, about 0.01% sodium hydroxide, and about 50% water. The composition has a lubricity of 33 to about 466. The personal lubricant composition attaches to mucous membranes and is not readily washed off. Since the composition already contains water, no heating or warming reaction occurs when the lubricant is applied to the body and the glycerin comes in contact with body-generated moisture.
U.S. Pat. No. 6,139,848 to Ahmad et al. discloses stable personal lubricant compositions containing at least one water-soluble polyhydric alcohol, a water-soluble polymer derived from cellulose, tocopherol or a tocopherol derivative, a nonionic water-soluble or dispersible emulsifier, and water. The lubricious, oily tocopherol or tocopherol derivative is present as an emulsion in the personal lubricant. The emulsifier preferably is a polyalkylene emulsifier chosen from the group consisting of polyoxyethylene sorbitan monostearate, commonly known as Tween 60 or Polysorbate 60, and polyethylene glycol ether of isocetyl alcohol (commonly known as Isoceteth 20 or Arlasolve 200, which is available from ICI Americas, Inc, New Castle, Del.). The water-soluble polyhydric alcohol serves to increase the lubriciousness of the compositions. The water-soluble cellulose-derived polymer serves to impart the desired slipperiness and viscosity to the composition. Water is desired in sufficient quantity to be delivered as moisture to the mucous membranes and to provide consistency and viscosity to the composition. The nonionic surfactants emulsify tocopherol, tocopherol acetate or other tocopherol derivatives into a microemulsion in which the internal or oil phase is reduced to very small globules measuring 2 or less than 2 microns in size. Due to their immensely small size, the emulsion globules do not coalesce and serve to assist in maintaining the homogeneity of the emulsions and to preserve physical stability of the compositions. Since the polyhydric alcohol (glycerin) is already combined with water, no heating or warming reaction occurs when the lubricant is applied to the body.
U.S. Patent Application Publication No. 2001/0039380 to Larson et al. discloses in vivo biocompatible acoustic coupling media comprising polyethylene oxide (PEO), at least one of polyalkylene glycols and polyhydric alcohols, and the balance water. Since water is already added to polypropylene alcohol, the exothermic reaction of mixing has already occurred, and no additional warming occurs when the lubricant is used.
U.S. Patent Application Publication No. 2003/0207772 and International Patent Application Publication No. WO 03/092651 to Ahmad et al. (see also U.S. Pat. App. Pub. No. 2003/0211161 and Int'l Pat. App. Pub. No. WO 03/092652) disclose warming and nonirritating lubricating compositions containing polyhydric alcohols and an insulating agent. The polyhydric alcohol comprises glycerin, alkylene glycol, polyethylene glycol, or a mixture thereof. The alkylene glycol is selected from the group consisting of propylene glycol, butylene glycol and hexylene glycol, whereas the polyethylene glycol is selected from the group consisting of polyethylene glycol 300 and polyethylene glycol 400. The insulating agent is selected from the group consisting of honey, isopropyl myristate and isopropyl palmitate. A warming action is created by the heat released during dissolution of the polyhydric alcohol in water, and the insulating agent retains the heat. The insulating agent is an essential part of the composition of the lubricant, and reduces the spreading capability of the warming lubricant.
U.S. Patent Application Publication No. 2003/0232090 and International Patent Application Publication No. WO 03/092650 to Ahmad et al. disclose warming and nonirritating lubricating compositions. Also disclosed are substantially anhydrous, warming, non-toxic and nonirritating lubricating compositions containing polyhydric alcohols, a hydroxypropylcellulose gelling agent and, alternatively, a pH-adjusting agent for treating fungal and bacterial infections. The polyhydric alcohol comprises glycerin, alkylene glycol, polyethylene glycol, or a mixture thereof. The alkylene glycol is selected from the group consisting of propylene glycol, butylene glycol and hexylene glycol, whereas the polyethylene glycol is selected from the group consisting of polyethylene glycol 300 and polyethylene glycol 400. The insulating agent is selected from the group consisting of honey, isopropyl myristate and isopropyl palmitate. The use of insulating agents reduces the spreading capability of the warming lubricant.
U.S. Patent Application Publication No. 2004/0037911 to Letourneau et al. discloses a genital lubricating composition. The composition comprises (i) fatty acids and/or homeopathic dilutions of plant extracts and (ii) a physiologically acceptable carrier. According to a preferred embodiment, the genital lubricant composition comprises about 0.05% to about 0.5% hemp seed oil and a physiologically acceptable carrier so that it forms a lotion, a cream or a gel. The composition is particularly useful for use as a vaginal moisturizer, or as a personal lubricant for use prior or during sexual intercourse. The fatty acid can be hemp oil, linoleic (C18:2) and/or linolenic (C18:3) acid. The plant extracts include extracts from Caladium seguinum, Sepia officianalis, Lycopodium clavatum, and Onosmodium virginanium. The exact composition of carrier is not disclosed. This lubricant does not have any polyhydric alcohol and does not produce a warming sensation.
U.S. Patent Application Publication No. 2004/0086575 to Smith discloses anti-viral compositions. The anti-viral compositions contain at least one zinc compound, at least one phenolic antioxidant (and optionally other ingredients), and a pharmaceutical carrier. The zinc compound is selected from the group consisting of zinc, zinc chloride, zinc acetate, zinc citrate, zinc sudoxicam, zinc sulfate, zinc nitrate, zinc carbonate, zinc tartrate, zinc maliate, zinc lactate, zinc aminoacetate, zinc aspartate, zinc glutamate, zinc propionate, zinc oleate, zinc benzoate, zinc gluconate, zinc butyrate, zinc formate, zinc glycerate, zinc glycolate, zinc oxide, zinc ethylenediamine tetraacetate, zinc pentosan polysulfate, zinc oxyacetate, and hydrates. The phenolic antioxidant comprises at least one compound represented by the formula:

wherein each R is independently an aliphatic hydrocarbon residue, with or without oxygen, comprising 1 to about 12 carbon atoms, x is from 1 to 3, y is from 0 to 3, z is from 1 to 3, and x+y+z is 6 or less. The pharmaceutical carrier comprises at least one of water, alcohol, fatty acids, fatty acid esters, and waxes. The composition does not function as a lubricant.
U.S. Patent Application Publication No. 2004/0138074 to Ahmad et al. discloses substantially anhydrous, warming, non-toxic and nonirritating lubricating compositions containing polyols and preferably an insulating agent. The substantially anhydrous lubricant composition comprises a polyol, which increases in temperature by at least about 5° C., upon exposure to moisture and which has a maximum Energy Release Index of at least about 11 mJ/mg. The polyhydric alcohol is selected from glycerin, alkylene glycol, polyethylene glycol, polypropylene glycol, PEGylated compounds, block copolymers comprising polyalkylene glycol, and their mixtures. The use of insulating agents, such as honey, isopropyl myristate and isopropyl palmitate, reduces the spreading capability of the warming lubricant.
European patent document EP 0636374 to Tseng discloses a spermicidal anti-viral lubricating composition containing an antiviral alkylphenoxypolyethoxyethanol spermicide, a water-soluble polymeric gel matrix, and a solubilizer, which permits the spermicide to be compatible with the gel matrix. Preferably, a polyethoxylated compound, such as polyethoxylated castor oil, is used. There is no warming agent present in the lubricant, since the water-soluble polymer functions as the lubricating agent.
Japanese patent document JP 2292212 to Hans Eke Rennaruto Bidesutoreemu discloses a sterilizable gel. This sterilizing gel comprises a carboxypolymethylene polymer (carboma) and 1-90% polyhydric alcohol for stabilization (e.g., ethylene glycol). The carboma can be sterilized by assistance of the polyhydric alcohol and avoids deterioration of the gel when the gel is sterilized by γ-radiation derived from cobalt 60. This is not a warming gel and polyhydric alcohol is only used to prevent discoloration during γ-radiation.
Japanese patent document JP 2003183115 to Saijo discloses a poikilothermal lubricant. The lubricant may contain ingredients that cause cooling or warming. The warming or cooling ingredient is a dispersant that is not water-soluble and is protected by a polymeric coating. It is unclear what is the nature of the warming agent and what is the mechanism of the warming action.
International Patent Application Publication No. WO 93/18740 to Dunbar discloses a shaving gel. The water-based, non-foaming, shaving gel comprises from 0.05 to 4.0% of a carboxypolymethylene, from 2.00 to 52.0% of a polyhydric alcohol, and, optionally, a silicone derivative, an antipruritic agent, preservative agents, a chelating agent, a neutralizing agent, a solubilizing agent, a UV light-absorbing agent, or a perfume. The preferred polyhydric alcohol is glycerin. The gel is applied directly to dry skin and hair prior to shaving with a razor blade and provides a close, comfortable and well-lubricated shave. The shaving gel does not provide a warming effect.
Notwithstanding the advances in the field of lubricants, and more particularly in the field of warming lubricants and related articles, there remains a need in the art for a warming lubricant that provides effective elastohydrodynamic lubrication as evidenced by improved spreadability on skin, condoms and other surfaces with which it is brought in contact.